Surgical cutter operated with direct current
10881454 ยท 2021-01-05
Assignee
Inventors
- Sebastian Schostek (Tubingen, DE)
- Chi-Nghia Ho (Reutlingen, DE)
- Michael Melbert (Tubingen, DE)
- Marc O. Schurr (Tubingen, DE)
- Thomas Gottwald (Kochel, DE)
Cpc classification
A61B18/1445
HUMAN NECESSITIES
A61B2018/142
HUMAN NECESSITIES
A61B18/1447
HUMAN NECESSITIES
International classification
Abstract
A minimally invasive surgical implant-cutting instrument of the bipolar type, operated with direct current, with an instrument head which is located at the distal end of an instrument shank, wherein at least two mutually opposing instrument branches, preferably of the linear type, are arranged on the instrument head and between them define a cutting gap for receiving an electrically conductive implant or implant section between them. The electrodes are formed on the mutually facing longitudinal sides of the branches or these are each equipped with at least one electrode, which electrodes are in turn shaped at their mutually facing longitudinal sides to form a cutting edge in order to effect a quasi-linear or punctiform physical contact engagement with the electrically conductive implant or implant section for an electrical short circuit of the mutually opposing electrodes.
Claims
1. A surgical implant-cutting instrument of bipolar type, operating on direct current, the implant-cutting instrument comprising: an instrument head on which at least two mutually opposing instrument branches are arranged which between them define a cutting gap extending in a longitudinal direction of the implant-cutting instrument, for receiving therebetween an electrically conductive implant or implant section; a current control device; and an electric/electronic contact quality detection device, wherein mutually facing longitudinal sides of the at least two mutually opposing instrument branches each form an electrode or are each equipped with at least one electrode, wherein at least one electrode is spherical cap-shaped so that the electrodes achieve at their mutually facing sides a punctiform contact, wherein the current control device is configured to apply to the electrodes a DC cutting current comprising a direct current of predetermined or adjustable current strength in a pulsed or timed way such that a quantity of current in at least one current pulse or cutting impulse is sufficient to melt, from the outside, a wire portion of the implant in contact between the electrodes at locations where the electrodes and the wire portion of the implant contact each other, and wherein the electric/electronic contact quality detection device is configured to perform a contact-quality detection test sequence prior to a cutting operation of the instrument and chronologically before application of the DC cutting current to the electrodes, or separately and independently from the cutting operation, the contact-quality detection test sequence providing an application to the electrodes of a test current below the DC cutting current, or an application to the electrodes of the DC cutting current but with a test impulse duration below a duration of the at least one current pulse or cutting impulse, in each case in order to determine a contact resistance between the electrodes and the implant or implant section, according to a principle of four-conductor-measurement.
2. The implant-cutting instrument according to claim 1, wherein a pulse width and/or the current strength is set or is settable via the current control device for obtaining a required quantity of current.
3. The implant-cutting instrument according to claim 1, wherein the electrodes are each shaped at their mutually facing sides to form a spherical cap whereby contact arises when the electrodes are brought together, in order to effect a punctiform physical contact engagement with the electrically conductive implant or implant section to be introduced therebetween, for an electrical short circuit of the mutually opposing electrodes.
4. The implant-cutting instrument according to claim 1, wherein DC current impulses of predetermined current strengths of up to 200 amperes are applied in a time period smaller than one second and in a controlled manner to the electrodes between which the cutting gap is formed in the longitudinal direction of the instrument.
5. The implant-cutting instrument according to claim 1, wherein a voltage lies below a limit of 48 Volts for a low voltage.
6. The implant-cutting instrument according to claim 1, wherein the at least two mutually opposing instrument branches are rigidly fixed to the instrument head.
7. The implant-cutting instrument according to claim 1, further comprising an actuating mechanism configured to move or set the at least two mutually opposing instrument branches to change a cutting gap width in a defined way.
8. The implant-cutting instrument according to claim 1, wherein the at least two electrodes and/or the at least two mutually opposing instrument branches are oriented with respect to each other to be essentially V-shaped so that the cutting gap formed therebetween narrows in a proximal direction, continuously or in a convex curve shape.
9. The implant-cutting instrument according to claim 1, further comprising a biasing device provided at the instrument head, the biasing device being configured to bias the electrodes and/or the instrument branches against each other with a predetermined biasing force so that an implant material is introduced therebetween in an insertion process and is automatically compressed or crushed by the insertion process itself.
10. The implant-cutting instrument according to claim 1, wherein in a case of falling below a threshold value the electric/electronic contact quality detection device is configured to output a warning signal and/or block a subsequent application of the DC cutting current.
11. The implant-cutting instrument according to claim 1, wherein the electric/electronic contact quality detection device is configured to adjust the amount of the DC cutting current to be supplied for the cutting operation correspondingly to the contact resistance between the electrodes and the implant or implant section that is determined by the contact-quality detection test sequence.
12. The implant-cutting instrument according claim 1, wherein the electric/electronic contact quality detection device is configured to verify in the contact quality detection test sequence whether the DC cutting current required for melting of the implant or implant section brings about a heating of the implant-cutting instrument below a thermal load capacity of supply lines and/or of the electrodes.
13. The implant-cutting instrument according to claim 1, wherein the at least two mutually opposing instrument branches or the electrodes are made from a heat resistant material whose resistance-adjusted specific melting energy is larger than 5.99 10.sup.15 J m.sup.4.sup.1.
14. The implant-cutting instrument according to claim 1, wherein the at least two mutually opposing instrument branches or electrodes mounted to them are configured springily resiliently.
15. The implant-cutting instrument according to claim 1, wherein the at least two mutually opposing instrument branches or the electrodes mounted to them are mounted at the instrument head for an automatic setting of gap width such that implants of different material thicknesses can be introduced into the cutting gap for a short-circuit of the electrodes.
16. The implant-cutting instrument according to claim 1, wherein in a case of reaching or exceeding a threshold value, the electric/electronic contact quality detection device is configured to output an acceptance signal and/or permit a subsequent application of the DC cutting current.
17. A surgical implant-cutting instrument of bipolar type, operating on direct current and comprising: an instrument head on which at least two mutually opposing instrument branches are arranged to define a cutting gap between the at least two instrument branches and extending in a longitudinal direction of the instrument, the cutting gap being configured to receive an electrically conductive implant or implant section, wherein mutually facing longitudinal sides of the at least two mutually opposing instrument branches each form an electrode or are each equipped with at least one electrode, the electrodes being shaped so that they achieve at their mutually facing sides a punctiform contact or an essentially one-dimensional linear contact extending in a longitudinal direction of the electrodes, a current control device configured to apply to the electrodes a DC cutting current comprising a direct current of predetermined or adjustable current strength in a pulsed or timed way such that a quantity of current in at least one current pulse or cutting impulse is sufficient to melt, from the outside, a wire portion of the implant in contact between the electrodes, at locations where the electrodes and the wire portion of the implant contact each other, and an electric/electronic contact quality detection device configured to perform a contact-quality detection test sequence in the event of a cutting operation of the instrument and chronologically before the resulting application of the DC cutting current to the electrodes, or separately and independently from the cutting operation, wherein the contact-quality detection test sequence provides an application to the electrodes of a test current below the DC cutting current, or an application to the electrodes of the DC cutting current but with a test impulse duration below a duration of the at least one current pulse or cutting impulse, in each case in order to determine a contact resistance between the electrodes and the implant or implant section, according to a principle of four-conductor-measurement.
18. The surgical implant-cutting instrument according to claim 17, wherein the electric/electronic contact quality detection device is configured to verify in the contact quality detection test sequence whether the DC cutting current required for melting of the implant or implant section brings about a heating of the implant-cutting instrument below a thermal load capacity of supply lines and/or of the electrodes.
Description
(1) The invention will be explained in more detail below with reference to preferred embodiment examples with reference to the accompanying drawings.
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(16) The surgical implant-cutting tool of the bipolar type shown schematically in
(17) As can furthermore be seen from
(18)
(19) Therefore the instrument branches 2 are connected to the instrument head 1 and in addition executed to be rigid. Electrically conductive electrodes 10 are arranged on the mutually facing longitudinal sides of each branch 2, which electrodes 10 are connected via two electrical conductors (not shown) inside of the instrument shank 6 with the DC current generator 8. The branches 2 may thereby themselves form the electrodes 10, for which they must however be electrically insulatedly fixed to the instrument head 1. Alternatively the instrument branches 2 may however even be equipped/loaded with external electrodes 10. The formation/arrangement of the electrodes 10 as well as of their connection to the DC current generator is the same for all the variants that are described in the following, so that it is not described repeatedly.
(20) According to the variant shown in
(21) According to
(22) According to
(23) A third variant of a branch construction is shown in
(24) According to
(25) In
(26) Accordingly the instrument branches 2 are basically spaced or spaceable such that the cutting gap 4 which forms longitudinally therebetween has a gap width which permits/ensures an introduction of an implant or implant section 18 (stent wire) into the gap 4 when coming into contact with the two mutually opposing longitudinal branches 2/electrodes 10. Preferably the instrument branches 2 are for this purpose banana-shaped/convexly rounded at least in the region of their distal (free) end sections, to form a convex longitudinal curve, at least in longitudinal sections, at the mutually facing branch sides. In this way the cutting gap 4 tapers not (necessarily) linearly, but rather along a curve. It goes without saying that the electrodes 10 are suited to fit this curve path.
(27) If now a metallic implant or an implant section 18 is introduced into the gap 4, generally the implant material already at the distal end portion of the instrument branches 2 comes into contact with the respective electrodes 10 and shorts them, whereby because of the applied power current the implant material between the electrodes 10 is heated and melted.
(28) If now the instrument head 1 moves forwards, the implant 18 slides deeper and deeper into the tapering cutting gap 4, wherein the electrodes 10 preferably also dissect the melted implant material.
(29) The following parameters are, among others, of importance for the described cutting process: The electrodes 10 or the instrument branches 2 should preferably have a form which favors the dissecting process. The contact resistance between the electrodes 10 and the implant 18 should be as high as possible in order to securely melt the implant material in the contact region (i.e. from the outside inwards), but additionally to leave implant regions further away to be unheated as much as possible. The energy input into the implant material should take place such that a heat dissipation into the surrounding patient tissue remains as small as possible, even in the absence of additional protection measures.
(30) For this reason the instrument branches 2 and/or at least the electrodes 10, according to a preferred exemplary embodiment of the invention, comprise a sort of blade shape with a narrow (sharp) longitudinal edge on the mutually facing longitudinal sides of each branch 2. By means of this form an (essentially one-dimensional) line-like or point-like contact with the implant is achieved, whereby at this position the contact resistance and with it the current density and the material heating created in this way becomes particularly high with application of DC current. A preferred construction for an instrument branch 2 and/or electrode, according to the invention, is shown in
(31) According to
(32) Each branch 2 is shaped at its proximal end section into a sort of hollow pin 2a which is inserted in a corresponding receiving socket/receiving sleeve 1a on sides of the instrument head 1, in accordance with
(33) The distal section of each branch 2 is formed (ground/milled) into a blade shape having a partially circular-shaped back of the blade 2b and a blade edge 2c which is curved to be banana shaped in the longitudinal direction. Alternatively the blade shape may be configured such that two (straight) longitudinal sections are provided standing obtusely with respect to each other, whereby the banana shape is approximated with the forming of a single kink. In this way a narrow (sharp) longitudinal edge/cutting edge 2e occurs at the one longitudinal side of each branch 2, which extends arcuately in the longitudinal branch direction (corresponding to the longitudinal direction of the instrument).
(34) Two conductor bundles 6a, 6b consisting in each case of a plurality of individual litz wires project from the instrument shank 6 at its distal end, wherein the conductor bundles 6a, 6b are both inserted in the receiving sleeves 1a and crimped. In this way each instrument branch 2 or electrode 10 comes into electrical contact with a respective conductor bundle 6a, 6b, which in turn are connected to the DC current generator.
(35) By means of the foregoing instrument design the conductor bundles 6a, 6b can achieve a comparatively large conductor thickness despite a low maximum shank outer diameter in order to conduct a sufficient electric current with comparatively lower current density (without it heating up). The passage from each conductor bundle 6a, 6b is made preferably from copper on the associated branch 2, preferably from wolfram/steel over the clamping sleeve 1a and thereby without large losses. Each branch 2 thereby forms a cutting edge 2e, which also simultaneously defines the contact line with the implant 18 and which thus generates a high contact resistance (and with it a high current density). At the same time the cutting edge 2e serves preferably for the mechanical dissecting of the electrically melted implant material.
(36) In order to ensure the correct contact closure with the implant 18, the surgical instrument has a contact-quality-detection function, as will be described in the following with reference to
(37) The contact grip between instrument and implant is functionally depicted in
(38) But now the situation can arise that the implant 18 is not clamped exactly between the contact edges 2e of the instrument branches 2 or electrodes, but rather bears over a large area on the electrode of each branch 2. In this way the contact resistance between the electrode and the implant would be distinctly reduced (current density reduces) such that much more current would have to be conducted in the conductors 6a, 6b in order to achieve a melting of the implant material. This serves to avoid heating of the entire implant.
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(40) To understand the material choice/material properties according to the invention, the term resistance-adjusted specific melting energy e is to be introduced, as is given in
(41)
having the following parameters:
e resistance-adjusted specific melting energy
c specific heat capacity
V material volume
mass density
T.sub.S melting temperature
T.sub.O temperature before energy input
r specific electrical resistance
(42) The situation according to
(43) Conductor: copper
(44) Electrode: unalloyed steel
(45) Metal stent: nickel-titanium
(46) The resistance-adjusted specific melting energy e for each of these metals is approximately (given in 10.sup.15 J m.sup.4 .sup.1):
(47) Copper: 210
(48) Unalloyed steel: 39
(49) Nickel-titanium: 4.86
(50) This means that with identical current flow having identical current density, nickel-titanium melts faster than unalloyed steel by the ratio 39 to 4.86 (approx. 8), while nickel-titanium melts faster than copper by the corresponding ratio 210 to 4.86 (approx. 43). This assumes the same current density in the material. Moreover this means that it is made possible, through material choice on the basis of the resistance-adjusted specific melting energy, to dose an electrical direct current which flows through the conductor, the electrode and the stent material, such that it selectively melts the stent material while the electrodes and the conductor do not reach the melting temperature during the current impulse. Preferably the materials are selected such that the resistance-adjusted specific melting energy of the materials which are not to be melted (in particular conductor material and electrode material) is at least twice the resistance-adjusted specific melting energy of those materials that are to be melted (in particular the material of the implant to be cut).
(51) Furthermore, and on this basis, it is provided according to the invention to control the current density such that the current density in the target metal to be melted is higher than in the conducting lines and electrodes of the instrument. This is solved by the configuration, according to the invention, of the electrodes whereby a punctiform or linear contact surface is created between electrode and the metal to be cut, which leads to a high current density. In this way the melting of the target material is additionally accelerated in comparison with the electrode material and conductor material. The contact quality between electrode and the metal to be melted is strongly dependent on each gripping situation. An optimal contact quality is promoted by the configuration, according to the invention, of the electrodes. In addition, according to the present invention it is useful to carry out an electrical check of the contact quality.
(52) The resistance path along the electrical path is marked out in
(53) Consequently the individual conductor sections of the electrical path form individually identifiable resistances from which only the contact resistances R.sub.K1,2 are initially of interest. The conducting path is thereby formed from the conductor bundles 6a, 6b in the instrument shank 6, the branches 2, the contact locations as well as the implant 18. In order to determine the contact resistances exclusively, for example a small test current below the later cutting current is applied to the electrical path and a reference voltage is directly tapped at the distal end of the conductor bundles 6a, 6b. The conductor bundle resistance may be calculated from the difference between the applied voltage and the tapped voltage. Furthermore the contact resistance R.sub.K1,2 can be determined in this way. According to the amount of the contact resistance R.sub.K1,2, the contact-quality-detection function has the ability to give a warning signal for an incorrect gripping position and/or to block the supply of a cutting current and/or to correct the amount of the cutting current to below the load limit of the conductor bundles 6a, 6b.
(54) It should be noted at this point that in place of the small test current, alternatively the cutting current or power current itself may be used for test purposes, wherein in this case the cutting current may be applied for only a short time in order to keep the energy input into the implant smaller than the energy input that would be required to melt the implant material.
(55) For the subsequent cutting according to
(56) Operation of Metal Separation with DC Current According to the Present Invention
(57) Basic Energy Consideration
(58) The crystal lattice of a metal has a characterizing thermal energy which manifests itself in vibrations of the atoms of the lattice. Thermal energy is thereby a kinetic energy.
(59) The thermal energy of a material is dependent on the temperature T, the mass m and a material constant c (specific heat capacity), and can be expressed with the following formula:
E.sub.th=c.Math.m.Math.T
(60) An electric direct current which flows through a metal lattice leads to an excitement of the lattice atoms due to collisions or interactions between the flowing charge carriers and the lattice atoms, and therefore to an increase in its kinetic energy and consequently to an increase of the thermal energy (heating). The electrical energy of a DC impulse is dependent on the electrical power P and the pulse duration t:
E.sub.et=F.Math.t
(61) The thermal energy as well as the electrical energy is usually given with the units of Watt Seconds (Ws) or Joules (J).
(62) When flowing through a piece of metal, the electrical energy is completely converted into thermal energy which leads to a thermal energy difference between before (t0) and after (t1). During the duration of the impulse the temperature difference between the section of the metal lattice through which current flows and adjacent structures leads to an outflow of thermal energy E.sub.Diss into the surroundings. This outflow is dependent on various material constants, which are bundled into the variable k and are not specified in greater detail, as well as on the integral of the temperature difference with respect to the time t:
E.sub.Diss=k.Math..sub.tT(t).Math.dt
(63) The outflow of the thermal energy into the surroundings according to the above relationship has a strong dependence on the impulse duration t. That is, the shorter the pulse, the less thermal energy flows away.
(64) The difference in the thermal energy between before (t0) and after (t1) can be described as follows:
E.sub.th,t1=E.sub.th,t0+E.sub.elE.sub.Diss
(65) The Temperature rise T can be calculated as follows:
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(67) With use of the mass density formula and separation of the material constants there results the following proportional relationship:
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(69) According to the above relationship one has thus three possibilities to increase the temperature rise in an implant material. a) One increases the supplied electrical energy E.sub.el b) One reduces the volume V through which direct current flows c) One reduces the impulse duration (in order to minimize the heat dissipation effect)
(70) A reduction of the impulse duration according to point c) leads simultaneously to a reduction of the electric energy E.sub.el according to point a). However this may be compensated by an increase of the electrical power P. It is therefore appropriate to minimize the impulse duration t (in order to minimize the heat dissipation during the energy input) and simultaneously to maximize the electrical power P (in order to deliver sufficient electrical energy E.sub.el despite lower impulse duration).
(71) It is therefore provided according to the invention that the bipolar cutting instrument creates a local heating of a gripped piece of metal (with the aim of local melting), which heating is as strong as possible, while making a required input of electrical energy as small as possible. Here the gripped target metal should be melted while the instrument material should remain intact and the surrounding tissue should remain undamaged.
(72) Heating Process, Influence of Material Constants
(73) As is shown in
(74) The melting of an elemental volume by electric direct current according to
(75) The thermal energy E.sub.th that is necessary to melt an elemental volume according to
E.sub.th.Math..Math.V.Math.(T.sub.ST.sub.O)
(76) T.sub.O=38 C. (body temperature) and a standard volume of 1 mm.sup.3 gives rise to values for the melting energy per mm.sup.3 according to the following table (
(77) In conclusion a surgical implant-cutting instrument of the bipolar type, operated with direct current, is disclosed, with an instrument head which is located at the distal end of an instrument shank and which is provided for minimally invasive insertion of the instrument into a patient's body, wherein at least two mutually opposing instrument branches, preferably of the linear type, are arranged on the instrument head and between them define a cutting gap for receiving an electrically conductive implant or implant section between them. According to the invention electrodes are formed on the mutually facing longitudinal sides of the branches or these are each equipped with at least one electrode, which electrodes are in turn shaped at their mutually facing longitudinal sides to form a cutting edge in order to effect a quasi linear or punctiform physical contact engagement with the electrically conductive implant or implant section for an electrical short circuit of the mutually opposing electrodes.
(78) Detection of Contact Quality
(79) According to the invention it is provided to accomplish the melting of the target metal by means of a DC power current (in the range of approx. 100-150 amperes) via an endoscopic instrument. It is important here that the target metal of the implant is selectively melted, i.e. that the direct current melts the stent material but not the conductor/electrode material of the endoscopic surgical implant-cutting instrument. A suitable dose (setting) of current strength and impulse duration or impulse form is decisive for this purpose.
(80) The term contact quality is understood in this context to mean the conditions set for current density and current path length which arise when contacting of the implant material with the instrument. Influencing factors can for example be the concrete transformation of the gripped/contacted implant section. If the gripped/contacted implant section between the electrodes is thin and planar, there arises a small current density, but if it is narrow, there arises a high current density. The concrete contact situation can break down very differently in individual cases, such that different contact qualities result. In order to ensure a reliable cutting and at the same time to avoid an excessive energy input (which can lead to explosion effects or can damage the instrument), it is practical to adjust the current strength and impulse duration or impulse form.
(81) The contact quality may be performed via a resistance measurement. The current path can be described, according to
(82) R.sub.L1 Resistance of conductor 1
(83) R.sub.E1 Resistance of electrode 1
(84) R.sub.K1 Contact resistance (electrode 1-stent material) 1
(85) R.sub.M Resistance of the metal to be cut
(86) R.sub.K2 Contact resistance (electrode 2-stent material) 2
(87) R.sub.E2 Resistance of electrode 2
(88) R.sub.L2 Resistance of conductor 2
(89) The determination of contact quality occurs according to the principle of four-wire sensing. This is applied before the actual cutting process for the determination of appropriate cutting parameters (current strength, impulse duration and impulse form) as well as during the cutting process. The basic principle is shown in
(90) In an embodiment variant of the determination of contact quality a small test current is introduced into the instrument before the cutting process such that the test current flows via the electrodes through the stent material to be cut. The voltage drop U.sub.T between the two electrodes and created by the test current may be measured via two conductors which are in electrical contact with the electrodes but through which the test current does not flow. This corresponds to a measurement of the resistances R.sub.E1, R.sub.K1, R.sub.M, R.sub.K2 and R.sub.E2 in the equivalent circuit diagram, according to the principle of four-wire sensing. The test current lies distinctly below the power current, preferably in the milliampere range (e.g. 20 mA). In addition to the determination of the contact quality it may also be determined whether an electrically conductive contact was made at all.
(91) In a further embodiment variant of the determination of contact quality a test impulse is sent before the cutting process (preferably when a stable electrical contact has been established), through the implant material to be cut, which leads to heating but does not lead to melting. A heating leads to an increase in the specific resistance of the material and therefore to an increase in the voltage U.sub.T between the electrodes and determined according to the principle of the four-wire method. During this impulse a prognosis of the energy input required for melting may be computationally deduced based on the growth curves of the electrical resistance between the electrodes (which corresponds to the resistances R.sub.E1, R.sub.K1, R.sub.M, R.sub.K2 and R.sub.E2 in the equivalent circuit diagram). This may serve as basis for the setting of the cutting parameters.
(92) During the cutting process, the cutting process may be monitored from the monitoring of the voltage U.sub.T between the electrodes with the aim of adjusting the cutting parameters as necessary, such that e.g. a foreseeably too-low parameter setting is corrected.
(93) Furthermore the voltages U.sub.L1 and U.sub.L2 are determined. This takes place not only with the test current before the cutting process but also with the power current during the cutting process. Since the ohmic resistance of the conductor material changes with temperature, the ohmic resistance, and with it the temperature, can be ascertained by measurement of the voltage drop in the case of known current. This is appropriate in particular in order to recognize and avoid overheating of the instrument shank, through suitable setting of the cutting parameters or cancellation of the cutting process. The temperature coefficient of various conductive materials is shown in
(94) Since the test current is preferably many times smaller than the power current, it is appropriate to be able to optionally electronically amplify the measurement of the voltages U.sub.T, U.sub.L1 and U.sub.L2. A simplified suitable circuit is shown in